cer by the Food and Drug

Administration (FDA) in 1998, after

NCI released the results of the Breast

Cancer Prevention Trial (BCPT), a six-

year study of the drug. In BCPT,

tamoxifen was found to reduce the

incidence of breast cancer by 49 per-

cent. Based on that study, FDA

approved the drug for women at high

risk of developing invasive breast can-

cer. High risk was defined as women

age 35 and older who have a five-year

risk of at least 1.67 percent.

Using data on cancer risk factors

from the 2000 National Health

Interview Survey, researchers calculat-

ed the number of women in this

country eligible to take tamoxifen

based on FDA-approved indications.

They also projected the number of

white and black women who would

most likely have a net positive benefit

from taking the drug based on a bene-

fit-risk analysis. Because accurate data

on the frequency of adverse tamoxifen

effects in Hispanic women were not

available, estimates of how many

Hispanic women would likely benefit

from the drug could not be calculated,

they said.

The researchers estimated that 15.5

percent of women 35 to 79 years old in

this country, or about 10 million,

would be eligible to take tamoxifen

based on breast cancer risk alone.

When analyzed by race, 18.7 per-

cent of white women ages 35 to 79 in

the U.S., or 9.4 million, would be eli-

gible for tamoxifen, but only 4.9 per-

cent, or 2.4 million, are likely to ben-

efit from the drug. About 6 percent

of U.S. black women in the same age

range, or 430,000, would have a high

enough risk to take the drug, but

only 0.6 percent, or 43,000, would

likely derive a net benefit from it.

The rates are lower for black women

than white women, they said, because

the overall risk for breast cancer in

black women is lower and because the

rates of stroke, deep vein thrombosis

and pulmonary embolism are higher

than among white women. The results

for black women, however, are less sta-

ble than those for white women

because less is known about breast

cancer risk and the incidence of some

of the side effects in this group, said

Freedman.

In examining who would do well

on tamoxifen, the researchers found

that an overall net positive benefit was

related to age. Younger women are less

likely than older women to experience

the drug’s adverse affects. This means

that if a 40-year-old woman and a 60-

year-old woman had the same breast

cancer risk, the younger woman would

likely derive a better overall benefit

from the drug.

When the researchers did the age

analysis, they found the highest per-

centage of women likely to benefit

overall from tamoxifen were age 40 to

59. More than 8 percent of these

women would potentially gain from

chemoprevention, compared to 2.1

percent for women age 60 to 69.

In terms of preventing actual breast

cancers, the researchers estimated that

among the 2.4 million white women

who could likely benefit overall from

taking tamoxifen, 58,148 breast can-

cers would develop over the next five

years. But, if all these women took the

drug for that length of time and expe-

rienced the typical 49 percent reduc-

tion in breast cancer, 28,492 cases

could be prevented or deferred.

Further information on the risks

and benefits of taking tamoxifen for

breast cancer chemoprevention can be

obtained at NCI’s Web site http://cancer.

gov/bcrisktool.

All-In-One LifestyleChanges Lowers Blood Pressure

Lifestyle changes to prevent or

control high blood pressure need

not be made one at a time. But,

according to a study supported by the

National Heart, Lung, and Blood

Institute (NHLBI), with special

counseling, Americans can make all

the needed changes at the same time.

The best results were achieved when

the lifestyle changes included adoption

of the DASH diet, which is rich in

fruits, vegetables and lowfat dairy

products.

Results of the study, called PRE-

MIER, appear in the April 23, 2003,

issue of The Journal of the American

Medical Association.

“This is the first time a host of

behavioral steps to prevent or control

high blood pressure has been put

together in one intervention,” said

NHLBI Director Dr. Claude Lenfant.

“Past studies looked at one or two

changes at a time, and it was thought

that doing more would prove too hard.

But PREMIER shows that an all-in-

one approach works and can help

Americans reduce their blood pres-

sure, lowering their risk for heart dis-

ease and stroke.”

Recommended lifestyle steps to

prevent or control hypertension are to

• lose weight if overweight

• follow a heart-healthy eating plan,

which includes reducing salt and

other forms of sodium

• increase physical activity

• limit consumption of alcoholic

beverages

• quit smoking

Additionally, results of earlier studies,

published in December 2001 and April

1997, showed that the DASH diet sig-

nificantly lowers blood pressure, espe-

cially when combined with reduced

sodium intake. DASH stands for

“Dietary Approaches to Stop

Hypertension.”

PREMIER dealt with all of the

hypertension prevention and con-

trol steps. The study began in 1998

and was conducted at four clinical

August | September 2003 AWHONN Lifelines 317

centers. It included 810 participants

with blood pressures of 120-159 mm

Hg systolic and 80-95 mm Hg dias-

tolic. (Higher-than-optimal blood

pressure is 120-139/80-89 mm Hg;

stage 1 hypertension is 140-159/90-99

mm Hg.) At the start of the trial, 38

percent of participants had hyperten-

sion, and most were overweight and

sedentary. Sixty-two percent were

women and 34 percent were African

American.

Participants were randomly

assigned to one of three groups:

Advice-Only, Established and Estab-

lished Plus DASH. All three groups

received printed materials about blood

pressure and lifestyle. In addition:

• those in the Advice-Only group

received a 30-minute individual ses-

sion with a nutritionist, which did

not include counseling on how to

make behavior changes

• those in the Established group had

18 counseling sessions in 6

months—14 group meetings and 4

individual sessions. They kept track

of their diet, including calorie and

sodium consumption, and their

physical activity

• those in the Established Plus DASH

group had the same intervention

schedule as those in the Established

group, but also were taught to follow

the DASH diet and to record their

daily servings of fruits, vegetables,

dairy products and fat

After six months, blood pressure levels

had declined in all three groups but

the reduction was significantly more in

the two intervention groups and most

in the Established Plus DASH group.

Systolic blood pressure decreased on

average by 11.1 mm Hg in the

Established Plus DASH group, 10.5

mm Hg in the Established group, and

6.6 in the Advice-Only group; diastolic

blood pressure decreased on average

by 6.4 mm Hg in the Established Plus

DASH group, 5.5 mm Hg in the

Established group, and 3.8 in the

Advice-Only group.

The percentage of those with

hypertension dropped after 6 months

from 37 to 12 in the Established Plus

DASH group, from 37 to 17 in the

Established group, and from 38 to 26

in the Advice-Only group.

After 6 months, the percentage of

those able to control their high blood

pressure also was greatest in the Estab-

lished Plus DASH group. Seventy-

seven percent of hypertensives in that

group lowered their blood pressure to

under 140/90—by comparison, drug

treatment typically controls blood

pressure in about 50 percent of those

with stage 1 hypertension, according to

the article. About 66 percent of hyper-

tensives in the Established group and

48 percent of hypertensives in the

Advice-Only group brought their

hypertension under control. Other key

findings included:

• Optimal blood pressure (less than

120 mm Hg systolic and less than 80

mm Hg diastolic) was achieved in 35

percent of the Established Plus

DASH group, 30 percent of the

Established group, and 19 percent of

the Advice-Only group

• Fewer of those in the two interven-

tion groups who started the trial

without high blood pressure went on

to develop hypertension—6 percent

in the Established Plus DASH group,

8 percent in the Established group,

and 11 percent in the Advice-Only

group

• Consumption of fruits, vegetables

and dairy products significantly

increased in the Established Plus

DASH group, compared to the other

two groups. A third of those in the

Established Plus DASH group con-

sumed nine or more servings of

fruits and vegetables daily, compared

with only 6 percent of those in the

other groups. Fifty-nine percent of

those in the Established Plus DASH

group consumed two or more dairy

servings a day, compared with about

34 percent of the Advice-Only and

about 28 percent of the Established

group

• Significant weight loss occurred in

all groups—the average losses for

those who were overweight at the

start of the study were about 13

pounds in the Established Plus

DASH group, about 11 pounds

in the Established group, and

about 3 pounds in the Advice-

Only group

318 AWHONN Lifelines Volume 7 Issue 4